A Reinforcement Approach to Increase Use of CGM
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reinforcement for wearing CGM
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- age 13-26 years old;
- diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
- average A1c >7.5% and <14% during the year before study entry, and most recent A1c >7.5% but <14%;
- have ordered and received a CGM, but have not used a CGM >3 days a week on average during the past 6 months.
- test blood glucose levels at least 2 times per day on average;
- access to a computer with internet for uploading CGM data;
- access to a cell phone to communicate with research staff;
- English speaking, able to read at >5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.
Exclusion Criteria:
- have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
- have a major visual impairment;
- have a significant other medical condition that impacts diabetes management (e.g., rheumatoid arthritis, or other condition that requires steroid treatment);
- plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched.
- Fail to complete the baseline phase wearing the CGM.
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Reinforcement for wearing CGM
Arm Description
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Outcomes
Primary Outcome Measures
Change in the Proportion of days participants wear the CGM
CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the proportion of days when the patient wore the CGM. At the 6, 13, 19, 26 and 39 week study visits, data will be uploaded and exported into an Excel file to calculate the days.
Change in the number of weeks participants wear the CGM on at least 5 days
CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the number of weeks when the CGM is worn at least 5 days. At the 6, 13, 19, 26 and 39 week study visits, CGM data will be uploaded and exported into an Excel file to calculate the number of weeks when it is worn at least 5 days.
Change in A1c
Change in A1c will be evaluated at the week 6, 13, 19, 26 and 39 week study visits by finger prick (DCA Vantage,Siemons).
Secondary Outcome Measures
Full Information
NCT ID
NCT02907346
First Posted
July 25, 2016
Last Updated
August 26, 2020
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02907346
Brief Title
A Reinforcement Approach to Increase Use of CGM
Official Title
A Reinforcement Approach to Increase Use of CGM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic intervention to increase use of continuous glucose monitors (CGM) in adolescents and young adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her research team at University of Connecticut School of Medicine (UConn Health). The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. A 6-month pilot trial will be conducted with up to 20 patients receiving the intervention. The specific aims are:
Detailed Description
The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic intervention to increase use of continuous glucose monitors (CGM) in adolescents and young adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her research team at University of Connecticut School of Medicine (UConn Health). The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. A 6-month pilot trial will be conducted with up to 20 patients receiving the intervention. The specific aims are:
To estimate how well a reinforcement intervention increases usage of CGM. The proportion of days on which participants wear the CGM will be determined as well as the number of weeks during which CGM is worn at least 5 days. We will compare usage rates in the pilot trial to historical control data of patients initiating CGM.
To evaluate the association between CGM usage and A1c. We expect A1c will decrease over time in patients who receive the reinforcement intervention. Patients who continue using the CGM are expected to have greater decreases in A1c than patients who discontinue its usage.
Evaluations will be conducted at time of CGM initiation, and 6, 13, 19, 26, and 39 weeks after treatment initiation to assess effects of the intervention and estimate effect sizes.
In addition to the primary aims, secondary outcomes will also be evaluated. Continued use of CGM is expected to improve aspects of diabetes management and daily functioning. Predictors of continued CGM usage and improvements in A1c will also be evaluated.
Results from this pilot study will be instrumental for guiding a subsequent, larger and longer term randomized study for evaluating reinforcement interventions for improving uptake of CGM, other diabetes-related adherence behaviors, and long-term outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reinforcement for wearing CGM
Arm Type
Experimental
Arm Description
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Intervention Type
Behavioral
Intervention Name(s)
Reinforcement for wearing CGM
Other Intervention Name(s)
Reinforcement for CGM wear
Intervention Description
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Primary Outcome Measure Information:
Title
Change in the Proportion of days participants wear the CGM
Description
CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the proportion of days when the patient wore the CGM. At the 6, 13, 19, 26 and 39 week study visits, data will be uploaded and exported into an Excel file to calculate the days.
Time Frame
up to 39 weeks
Title
Change in the number of weeks participants wear the CGM on at least 5 days
Description
CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the number of weeks when the CGM is worn at least 5 days. At the 6, 13, 19, 26 and 39 week study visits, CGM data will be uploaded and exported into an Excel file to calculate the number of weeks when it is worn at least 5 days.
Time Frame
up to 39 weeks
Title
Change in A1c
Description
Change in A1c will be evaluated at the week 6, 13, 19, 26 and 39 week study visits by finger prick (DCA Vantage,Siemons).
Time Frame
up to 39 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 13-26 years old;
diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
average A1c >7.5% and <14% during the year before study entry, and most recent A1c >7.5% but <14%;
have ordered and received a CGM, but have not used a CGM >3 days a week on average during the past 6 months.
test blood glucose levels at least 2 times per day on average;
access to a computer with internet for uploading CGM data;
access to a cell phone to communicate with research staff;
English speaking, able to read at >5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.
Exclusion Criteria:
have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
have a major visual impairment;
have a significant other medical condition that impacts diabetes management (e.g., rheumatoid arthritis, or other condition that requires steroid treatment);
plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched.
Fail to complete the baseline phase wearing the CGM.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Tamborlane, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Reinforcement Approach to Increase Use of CGM
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